# China NMPA Product Recall - Fully Automated Fluorescence Immunoassay Analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/platinum-elmer-medical-diagnostics-products-shanghai-co-ltd/f9b6fd18-f71a-4f10-81a0-6605129b94b4/
Source feed: China

> China NMPA product recall for Fully Automated Fluorescence Immunoassay Analyzer by Platinum Elmer Medical Diagnostics Products (Shanghai) Co., Ltd. published March 17, 2017. Recall level: Level II. PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its fully automated fluorescence immunoassay analyzer.
- Company Name: Platinum Elmer Medical Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2017-03-17
- Product Name: Fully Automated Fluorescence Immunoassay Analyzer
- Recall Level: Level II
- Recall Reason: Some sliding bearings have defects and are at risk of corrosion when exposed to humid environments for extended periods. Once corroded, these bearings may cause damage.
- Discovering Company: PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Platinum Elmer Medical Diagnostics Products (Shanghai) Co., Ltd.
- Summary: PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Fully Automated Fluorescence Immunoassay Analyzer. The company identified a manufacturing defect in the sliding bearings of specific product batches. These bearings are susceptible to corrosion when exposed to humid environments over extended periods. Corrosion of these critical components could potentially impair the analyzer's performance and accuracy, posing a risk to diagnostic processes. The recall was publicly reported on March 17, 2017, under the oversight of the National Medical Products Administration (NMPA) in China. PerkinElmer has taken responsibility for the issue by recalling the affected units to mitigate any potential impact on patient diagnostics and maintain product quality standards. Detailed information regarding the models, specifications, and batch numbers involved was provided in an accompanying Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/platinum-elmer-medical-diagnostics-products-shanghai-co-ltd/04fb6867-6d1f-485b-a064-5d8bc4b5ac61/